PMA P180002S022
- Device
- Zephyr Valve Reigstry (ZEVR)
- Applicant
- Pulmonx Corporation
- PMA number
- P180002
- Supplement
- S022
- Product code
- NJK
- Decision date
- 2023-03-25
- Classification
- Anesthesiology
- Generic name
- Valve, pulmonary
- Approval order statement
- Approval for modifications to the protocol including an increase in study sites from 10 to 15 and minor clarification changes.
Current openFDA PMA Record#
- Device
- Zephyr Valve Reigstry (ZEVR)
- Applicant
- Pulmonx Corporation
- PMA number
- P180002
- Supplement
- S022
- Product code
- NJK
- Generic name
- Valve, pulmonary
- Decision date
- 2023-03-25
- Decision code
- APPR
- Date received
- 2023-02-23
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for modifications to the protocol including an increase in study sites from 10 to 15 and minor clarification changes.